BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID PCR TEST

    MDR report key: 11768921 · Received May 3, 2021

    Report

    Report Number
    MW5101133
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 26, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BINX HEALTH LTD.
    Product Code
    QLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED A FALSE POSITIVE RESULT FROM A BINX HEALTH COVID TEST. I HAD TESTED NEGATIVE 3 DAYS PRIOR TO THE POSITIVE RESULT. UPON RECEIVING THE POSITIVE RESULT, I HAD 3 ADDITIONAL PCR TESTS THAT ALL REPORTED NEGATIVE RESULTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656032 COVID PCR TEST COVID-19 TEST HOME COLLECTION KIT DEVICES QLW BINX HEALTH LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR